Non-implantable training method for training genioglossus muscle strength

The present invention relates to an in vitro training method and an in vitro device for training muscle strength and, more particularly, to an in vitro training method and an in vitro training device used for training the genioglossus muscle strength during a non-sleep period.

According to the investigation by the World Health Organization (WHO), up to one billion of adults (aged 30-69) suffer from obstructive sleep apnea (OSA), including 42 millions of OSA patients in the U.S., among which one in every five adults suffers from mild OSA, and one in every fifteen adults suffers from severe OSA. Furthermore, according to the statistics of the Taiwan Society of Sleep Medicine (TSSM), about 450,000 people in Taiwan have poor sleep quality due to apnea.

The major causes of sleep apnea include a narrow airway which is inherent or caused by obesity, or an airway blockage resulting from collapse which tends to occur due to insufficient muscle tension in the airway of an aged body. The types of blockage causing sleep apnea include nasal cavity blockage, soft palate blockage in the oral cavity, and tongue root blockage. About 70% of the patients (about 0.65 billions of people in the world, including at least 300,000 people in Taiwan) belong to the tongue root blockage type which is the most common. The tongue root blockage is strongly relevant to reduction in actuation of upper airway muscles and weakened activation of infrahyoid muscles. OSA patients not only snore (which adversely affects the sleep quality of the person sleeping nearby) but also have poor sleep quality, leading to drowsiness in the daytime and reduced concentration and, in severe cases, may even cause sudden death due to apnea during the sleep period.

However, medicines for treating sleep apnea are not available currently. Common conventional methods for improving sleep apnea include: (1) using a mandibular advancement device which is suitable for mild and moderate sleep apnea patients, but the patients are difficult to sleep due to a sensation of a foreign body in the oral cavity caused by the mandibular advancement device; (2) instrument therapy: for example, wearing a continuous positive airway pressure (CPAP) on the face of a patient during sleep, thereby continuously filling air into the airway and, thus, expanding the airway, but the CPAP instrument is bulky and expensive; (3) surgical treatment: for example, cutting the uvula or the tonsil to enlarge the airway, or implanting an electrical stimulation device to electrically stimulate the genioglossus muscle and other muscles of the upper airway during sleep to thereby increase the muscle tension of the upper airway muscles. As for mild and moderate sleep apnea patients who are difficult to accept or withstand the CPAP therapy, surgical implantation of an electrical stimulation device is considered. However, the operation involves infection risks, and removal of the device and re-implantation are required when the device malfunctions, and the electrical stimulation during sleep will adversely affect the sleep quality of the patient.

Thus, it is necessary to improve the conventional methods for improving sleep apnea.

To solve the above problems, it is an objective of the present invention to provide an in vitro training method for training genioglossus muscle strength, in which transdermal electrical stimulation is conducted during a non-sleep period to stimulate the genioglossus muscle for restoring the muscular tension through training, which avoids the operational risks of implantation and discomfort during the sleep period.

It is another objective of the present invention to provide an in vitro training device for training genioglossus muscle strength for carrying out the above method.

It is a further objective of the present invention to provide an in vitro training device for training genioglossus muscle strength, which is easy to use and carry.

As used herein, the term “a”, “an” or “one” for describing the number of the elements and members of the present invention is used for convenience, provides the general meaning of the scope of the present invention, and should be interpreted to include one or at least one. Furthermore, unless explicitly indicated otherwise, the concept of a single component also includes the case of plural components.

As used herein, the term “engagement”, “coupling”, “assembly”, or similar terms is used to include separation of connected members without destroying the members after connection or inseparable connection of the members after connection. A person having ordinary skill in the art would be able to select according to desired demands in the material or assembly of the members to be connected.

An in vitro training method for training genioglossus muscle strength according to the present invention includes adhering an electrode patch of an in vitro training device to a bottom of a chin of a user during a non-sleep period. The electrode patch receives an electrical stimulation signal from an electrical stimulation module to stimulate the genioglossus muscle of the user through transdermal electrical stimulation. The electrical stimulation signal has a voltage of 1-100 V, an electric current of 1-30 mA, a pulse width of 1-500 ms, and a frequency of 1-80 Hz.

Therefore, by the in vitro training method for training genioglossus muscle strength, transdermal electrical stimulation is conducted during a non-sleep period to stimulate the genioglossus muscle for restoring the muscular tension through training, which avoids the operational risks of implantation and discomfort during the sleep period. Thus, there are no operational risks, and the sleep quality is not adversely affected. Furthermore, the user may proceed with the electrical stimulation training at any convenient time and place, which can effectively increase the training convenience and comfort for the user, thereby increasing the user's intention of continuous use as well as the training effect.

In an example, the in vitro training method is preferably carried out once a day and preferably not more than one hour every time.

In an example, the in vitro training method may be carried out plural times a day, and the interval between two training times is at least one hour.

Furthermore, the present invention further provides an in vitro training device for training genioglossus muscle strength. The in vitro training device includes an electrode patch and an electrical stimulation module. The electrode patch includes a body surface adhering face and an assembling face opposite to the body surface adhering face. The body surface adhering face is configured to be adhered to a bottom of a chin of a user to align with a genioglossus muscle of the user. The electrical stimulation module is disposed on the assembling face and in electrical connection with the electrode patch. The electrical stimulation module is configured to send an electrical stimulation signal to stimulate the genioglossus muscle of the user through transdermal electrical stimulation. Therefore, aside from carrying out the above in vitro training method to improve the sleep apnea, the electrical stimulation module of the in vitro training device can be directly connected to the electrode patch without wires disposed therebetween, such that the whole device can be more compact and tidy and easier to use, carry, and maintain.

In an example, preferably, the body surface adhering face can be repeatedly adhered to and removed from a skin of the user. Therefore, the user can repeatedly use the same electrode patch, increasing the use efficiency of material.

In an example, the assembling face of the electrode patch may include at least one first electrical connecting portion. The electrical stimulation module may include a casing, at least one power source disposed in the casing, and at least one second electrical connecting portion in electrical connection with the at least one power source and located outside of the casing. The electrical stimulation module is preferably detachably coupled with the electrode patch. The casing may cover a portion of the assembling face. The at least one second electrical connecting portion may be in electrical connection with the at least one first electrical connecting portion. Therefore, replacement of the electrode patch is more convenient.

In an example, the electrical stimulation module may include a control unit located in the casing. The at least one power source may be in electrical connection with the control unit. The control unit may be configured to control the electrical stimulation signal sent to the electrode patch. Therefore, the structure of the in vitro training device can be simplified.

In an example, the control unit may be coupled with an intelligent device and may be configured to adjust a stimulation intensity and/or a frequency of the electrical stimulation signal through an application interface of the intelligent device. Therefore, the user can adjust the electrical stimulation effect according to needs and comfort at any time, thereby increasing the training effect and the training comfort experience.

In an example, the electrical stimulation signal may have a voltage adjustment range of 0-100 V, an electric current adjustment range of 0-30 mA, a pulse width adjustment range of 1-500 ms, and a frequency adjustment range of 1-80 Hz. Therefore, the user may start, adjust, pause, or stop the electrical stimulation according to needs, which improves the operational convenience and assures the use safety and the training effect.

When the terms “front”, “rear”, “left”, “right”, “up”, “down”, “top”, “bottom”, “inner”, “outer”, “side”, and similar terms are used herein, it should be understood that these terms have reference only to the structure shown in the drawings as it would appear to a person viewing the drawings and are utilized only to facilitate describing the invention, rather than restricting the invention.

With reference to, the present invention provides an in vitro training method for training genioglossus muscle strength. The method includes adhering an electrode patchof an in vitro training device T to a bottom of a chin of a user during a non-sleep period. The electrode patchreceives an electrical stimulation signal from an electrical stimulation moduleto stimulate the genioglossus muscle M of the user through transdermal electrical stimulation. The electrical stimulation signal has a voltage of 1-100 V, an electric current of 1-30 mA, a pulse width of 1-500 ms, and a frequency of 1-80 Hz. These parameters can be adjusted by a doctor according to professional judgement and the conditions of the patient, such as the personal demands of the patient (e.g., the thickness of the genioglossus muscle M or the electrical resistance of the feedback of the electrical stimulation). In this way, the genioglossus muscle can be trained effectively and safely.

Therefore, the in vitro training method according to the present invention may be carried out during the non-sleep period, e.g., 30 minutes before sleep. The muscle endurance of the genioglossus muscle M of the user can be trained through transdermal electrical stimulation. A supporting force of the genioglossus muscle M can also be trained and the original muscle tension of the genioglossus muscle M can be restored. Thus, the blockage of the airway due to sinking of the tongue during the sleep period can be improved, thereby improving the symptoms of sleep apnea. The in vitro training method may be preferably carried out once a day and preferably not more than one hour every time. In a case that the in vitro training method should be carried out plural times a day, the interval between two training times should be at least one hour.

With reference toshowing a preferred embodiment of an in vitro training device T capable of carrying out the above in vitro training method for improving sleep apnea. The in vitro training device T includes an electrode patchand an electrical stimulation modulein electrical connection with the electrode patch.

With reference to, the electrode patchhas excellent electrical conductivity and softness to assure that the electrode patchcan be firmly adhered to the skin of the user and is less likely to peel off. Specifically, the electrode patchincludes a body surface adhering faceconfigured to be adhered to a bottom of a chin of the user. Thus, the electrode patchcan remain in a position aligned with the genioglossus muscle M of the user. Preferably, the body surface adhering facecan be repeatedly adhered to and removed from the skin of the user, such that the user can repeatedly use the same electrode patch, thereby increasing the use efficiency of material. The electrode patchmay include at least one electrical conductive portionlocated on the body surface adhering face. The electrical conductive portionmay contact with the skin of the user to proceed with in vitro electrical stimulation on the user.

The electrical stimulation moduleis in electrical connection with the electrode patchand can be controlled to send an electrical stimulation signal (with a predetermined voltage, a predetermined electric current, a predetermined frequency, and a predetermined pulse duration) to the electrode patch. Therefore, the user's genioglossus muscle M can be stimulated by in vitro transdermal electrical stimulation through the electrode patch. The present invention is not limited to the type of electrical connection between the electrical stimulation moduleand the electrode patch. Namely, the electrical stimulation modulemay be electrically connected to the electrode patchvia plural wires. Alternatively, as shown in the figures illustrating this embodiment, the electrode patchmay include an assembling faceopposite to the body surface adhering faceand configured to assemble with and position the electrical stimulation module. Thus, the electrical stimulation modulemay be directly connected to the electrode patchto form an electrical connection, such that no wires are required between the electrical stimulation moduleand the electrode patchfor the electrical connection. Thus, the whole device can be more compact and tidy and is easier to use and carry.

The electrical stimulation moduleis preferably detachably assembled with the assembling faceof the electrode patch. Thus, the electrode patchcan be replaced when the electrode patchis damaged or malfunctions or the body surface adhering facebecomes not sticky enough. For example, the assembling faceof the electrode patchmay include at least one first electrical connecting portion. The electrical stimulation modulemay include a casing, at least one power sourcedisposed in the casing, and at least one second electrical connecting portionin electrical connection with the at least one power sourceand located outside of the casing. The electrical stimulation modulemay be rapidly coupled with the electrode patchvia magnetic attraction, such that the casingcovers a portion of the assembling face, and the at least one second electrical connecting portionis in electrical connection with the at least one first electrical connecting portion. The at least one power sourceof the electrical stimulation modulemay be replaced. Alternatively, the electrical stimulation modulemay include a charging portionfor charging the at least one power source, or the at least one power sourcemay be charged wirelessly. The present invention is not limited in this regard.

With reference to, the electrical stimulation modulemay further include a control unitlocated in the casing. The at least one power sourcemay also be in electrical connection with the control unitto provide electricity to the control unit. Furthermore, the electrical stimulation modulemay include a switchdisposed on the casingfor controlling power supply from the at least one power sourceto the control unit. The control unitcan control the electrical stimulation signal sent to the electrode patchand may be coupled with an intelligent device E, such as a mobile phone, a tablet, or a smart watch, which permits the user to proceed with personalized setting through an application interface of the intelligent device E according to the user's needs and comfort, thereby adjusting the stimulation intensity and/or the frequency of the electrical stimulation signal to improve the training effect and the training experience. For example, the voltage adjustment range may be 0-100 V, the electric current adjustment range may be 0-30 mA, the pulse width adjustment range may be 1-500 ms, and the frequency adjustment range may be 1-80 Hz. Thus, the user may start, adjust, pause, or stop the electrical stimulation according to needs.

With reference to, the user can use the in vitro training device T of this embodiment during the non-sleep period. In use, the electrode patchis firstly adhered to the bottom of the chin of the user by the body surface adhering faceof the electrode patch, and the casingof the electrical stimulation moduleis coupled with the assembling faceof the electrode patch. Then, the switchis pressed to activate the electrical stimulation moduleto directly start the electrical stimulation. Alternatively, the electrical stimulation moduleis in a standby state and can be operated through the application interface of the intelligent device E to start, pause, or set the time of electrical stimulation. Thus, the electrical stimulation of the present invention is not conducted during the sleep period, which not only prevents adverse effect on the sleep quality of the user but also permits the user to choose any time convenient to the electrical stimulation training in daily life, which can effectively increase the training convenience and comfort for the user to thereby increase the user's intention of continuous use. Furthermore, the in vitro training method of the present invention is not invasive and, thus, requires no devices to be implanted in the operation. This avoids the risks and inconvenience caused by the operational procedure and significantly reduces the burden to the user caused by the training.

In summary, the in vitro training method and the in vitro training device for training genioglossus muscle strength according to the present invention include the following advantages:

Although the present invention has been described with respect to the above preferred embodiments, these embodiments are not intended to restrict the present invention. Various changes and modifications on the above embodiments made by any person skilled in the art without departing from the spirit and scope of the present invention are still within the technical category protected by the present invention. Accordingly, the scope of the present invention shall include the literal meaning set forth in the appended claims and all changes which come within the range of equivalency of the claims. Furthermore, in a case that several of the above embodiments can be combined, the present invention includes the implementation of any combination.